Summer 2010
Uncovering New Treatments

Uncovering New Treatments Through Cardiology Clinical Trials

If you have a heart condition, you may want to ask your physician about participating in a cardiology clinical trial. Participants in clinical trials try new medications, treatments or devices that are years away from being made available to the public. You will receive close monitoring of your medical condition by a team of physicians and nurses who are experts in the area that is being researched. Thanks to the willingness of people who volunteer to participate in clinical trials, major life-saving medical advances have been developed.

What are clinical trials?
Clinical trials are research studies that evaluate new medications and/or treatments. The same clinical study is conducted at the same time in many hospitals, clinics and physicians’ offices all over the country and, in some cases, all over the world. Once the clinical trial is finished and the results are evaluated and reported, the data helps physicians prescribe better treatments and, sometimes, discover cures for medical problems.

How safe are clinical trials?
Before a trial is tested on people, the medication, device or treatment is studied extensively in various laboratories. By the time the new treatment reaches the clinical trial stage, there are many federal, medical and hospital safeguards in place.

There are risks and side effects with almost any treatment or drug. The same is true with those used in clinical trials. In a clinical trial, the side effects and risks of treatments and drugs are discovered, carefully examined and reported.

Participants’ rights are always protected. Bridgeport Hospital and all hospitals have an Institutional Review Board (IRB) that is responsible for protecting the rights, safety and well-being of patients involved in clinical research. The IRB, which must approve all trials being conducted at the hospital, consists of scientists, medical personnel, and community members who have no relationship to the clinical trial sponsors. The Food and Drug Administration and the department of Health and Human Services regulate the IRB and supervise and regulate clinical trials. In all clinical trials, participants are always free to withdraw at any time.

How can I join a clinical trial?
Because clinical trials are scientific studies, they have strict participation criteria. These are typically based on age, sex and medical condition requirements.

Who pays for the clinical trial?
There are no out-of-pocket costs to clinical trial participants. Most clinical trials are sponsored by a pharmaceutical company, a medical device manufacturer or the federal government. Participants may be required to use personal time to have blood tests or examinations. Occasionally, a modest reimbursement is included.

Bridgeport Hospital

Who conducts cardiology clinical trials?
At Bridgeport Hospital, the team includes two research nurses, an assistant and a cardiologist (physician) who is the Principal Investigator. The Principal Investigator is responsible for the entire project and reports to the hospital’s IRB, the trial sponsors and the federal government.

Do all participants get the medication or treatment being tested?
In a “double blind clinical trial,” one group of patients receives the treatment that is being studied and another group receives a placebo (a sugar pill or fake medication or treatment). In addition, both groups receive the same existing standard of care. The research team does not know which group you are in.

Clinical Trials at Bridgeport Hospital
Please visit www.bridgeporthospital.org/ClinicalTrials or call Tina Cullen, RN, at 203-384-4849. For national clinical trials, visit www.clinicaltrials.gov.

How a Trial Treatment Becomes Approved for Widespread Use

It can take several years before a new drug or treatment is deemed safe enough by the FDA to be approved for use in the United States. There are several phases of clinical trials that the new drug or treatment must pass before it is allowed to be used by or prescribed for the general public.

  • Phase One: The drug or treatment is tested to see if it is safely absorbed, metabolized (broken down) and eliminated (moved out) by the human body. Small groups of healthy volunteers participate in this phase. Their body’s reaction to the medication is closely monitored by a physician and the clinical team.
  • Phase Two: The experimental treatment or drug is given to carefully selected participants who are suffering from the disease that the drug is designed to treat. Several hundred participants are enrolled and typically half will receive the usual treatment or drug and half will receive the new treatment or drug. Costs of the drugs, treatments and lab tests are generally covered.
  • Phase Three: The new drug or procedure is measured against the current best treatment. This is the last stage before the FDA approves the drug for sale. Two positive, well-controlled studies are required by the FDA.

Late Summer Ratatouille
8 servings

Ingredients
  • 2 onions, sliced into thin rings
  • 3 cloves garlic, minced
  • 1 medium eggplant, cubed
  • 2 zucchini, cubed
  • 2 medium yellow squash, cubed
  • 2 green bell peppers, seeded and cubed
  • 1 yellow bell pepper, diced
  • 1 chopped red bell pepper
  • 4 roma (plum) tomatoes, chopped
  • 1/2 cup olive oil
  • 1 bay leaf
  • 2 tablespoons chopped fresh parsley
  • 4 sprigs fresh thyme
  • Salt and pepper to taste
Directions
  1. Heat 11/2 tablespoons of the olive oil in a large pot over medium-low heat. Add the onions and garlic and cook until soft.
  2. In a large skillet, heat 11/2 tablespoons of olive oil and sauté the zucchini in one-layer batches until slightly browned on all sides. Remove the zucchini and place in the pot with the onions and garlic.
  3. Sauté all the remaining vegetables, one layer at a time, adding 11/2 tablespoons olive oil to the skillet each time you add a new set of vegetables. Once each batch has been sautéed, add them to the large pot.
  4. Season with salt and pepper. Add the bay leaf and thyme and cover the pot. Cook over medium heat for 15 to 20 minutes.
  5. Add the chopped tomatoes and parsley to the large pot and cook for another 10-15 minutes. Stir occasionally.
  6. Before serving, remove the bay leaf and adjust seasoning.

Nutritional Information (per serving) 191 calories, 14.1 g total fat, 0 mg cholesterol, 13 mg sodium, 15.9 g total carbohydrates, 5.9 g dietary fiber and 3.2 g protein.

Need a Physician?

For a referral to an expert physician affiliated with Bridgeport Hospital, please call us toll free, 24/7, at 1-888-357-2396 or visit www.bridgeporthospital.org/FindPhysician.